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Resuscitation Registry in CHD

Pediatric Resuscitation Outcome in Children With Heart Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05373498
Acronym
PRO-CHD
Enrollment
400
Registered
2022-05-13
Start date
2022-08-18
Completion date
2032-12-31
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Congenital Heart Disease

Keywords

pediatric resuscitation outcome, congenital heart disease, neurodevelopmental outcome

Brief summary

Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially after cardiothoracic surgery. Due to a lack of data, the exact number of resuscitations in this patient cohort, as well as the morbidity and mortality, is unknown. This study aims to register all cardiovascular arrests in pediatric patients with congenital heart disease and study the mortality and morbidity with a special focus on the neurodevelopmental outcome.

Detailed description

Background and aim: Children with heart defects, especially those after heart surgery, have an up to ten times higher risk for an in-hospital cardiac arrest, compared to children without heart disease. Although this patient cohort is particularly vulnerable, these events and outcomes are not systematically monitored in Germany. We designed a prospective multicenter-registry study aiming to record in-hospital cardiac arrests of children with congenital- (CHD) and acquired heart disease in Germany. Methods: A web-based registry was designed, prospectively collecting data (patient´s demographics, CPR data, post-resuscitation care and clinical course, neurological outcome and follow-up), according to the Utstein template. All children (0-18 years) with heart disease suffering a cardiac arrest requiring resuscitation of ≥ two minutes will be included. The primary outcome is survival to discharge, the secondary outcome is morbidity, with a particular focus on neurological morbidity. An inclusion of 10-20 children/centre/year is anticipated. As this is an observational study, no intervention is planned. Results: This registry will provide data on the mortality, early and mid-term neurologic outcome, and quality of life after cardiac arrest of children with heart disease in Germany. Correlations between patients´ characteristics, resuscitation characteristics and post-resuscitation care with primary and secondary outcomes will be analyzed. Conclusions: By systematically recording and analyzing the outcome after in-hospital cardiac arrest in children with CHD, this study is an important first step to close knowledge gaps regarding the risk factors and outcome of cardiac arrest in this patient group, and aims to improve care and outcomes of these vulnerable patients.

Interventions

None listed

Sponsors

Heart Center Leipzig - University Hospital
CollaboratorOTHER
Zentrum für Klinische Studien Leipzig
CollaboratorOTHER
Deutsche Gesellschaft für Pädiatrische Kardiologie und Angeborene Herzfehler e.V.
CollaboratorUNKNOWN
Stiftung KinderHerz
CollaboratorUNKNOWN
Leipzig Heart Science gGmbH
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* congenital heart defects, congenital heart arrhythmia, familial cardiomyopathies, inflammatory heart diseases * pediatric resuscitation (chest compressions ≥2min) in hospital or on arrival in hospital * age \<18 years * informed consent of the parents or legal representative

Exclusion criteria

* absence or withdrawal of informed consent of the parents or legal representative * do-not-resuscitate-order (DNR)

Design outcomes

Primary

MeasureTime frame
survival to hospital dischargeuntil the date of discharge or death from any cause, whichever came first, assessed up to 2 months

Secondary

MeasureTime frame
Number of return of spontaneous circulationuntil the date of discharge or spontaneous circulation from any cause, whichever came first, assessed up to 2 months
Rate of morbidityuntil 2 years

Countries

Germany

Contacts

Primary ContactFranziska Markel, Dr. med.
Franziska.Markel@helios-gesundheit.de+49341865253025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026